Perinatal and Obstetric Medical devIces: Solutions for Equity (PROMISE)

Research question How do biases in medical tools and devices used during pregnancy and the neonatal period affect healthcare outcomes, particularly among minority ethnic and socio-economically disadvantaged communities, and what strategies can be developed to ensure equitable use of, and access to, these technologies? Background Medical devices used in pregnancy and neonatal care have the potential to contribute to biases, affecting maternal and neonatal health outcomes. An independent review, published in 2024, highlighted devices like pulse oximeters, AI tools, and polygenic risk scores as contributors to health inequalities, especially among minority ethnic groups. Understanding these disparities is essential for developing interventions to address the negative impacts of biased devices and healthcare practices. Aims and Objectives This study aims to investigate the use of medical devices during pregnancy and the immediate neonatal period, focusing on identifying biases that contribute to health inequities, particularly among minority ethnic and socio-economically disadvantaged communities. Objectives include mapping device use, gathering women's perspectives, identifying biases, and to create policy recommendations for ensuring that medical devices are not barriers to equitable care. Methods This study integrates both qualitative and quantitative methodologies with active patient and public involvement and engagement throughout to promote inclusivity. Patient & Public Involvement (PPI) We have engaged with new parents to develop this research proposal and have started to build a PPI advisory group. This group, led by our PPI co-applicant, will guide the research from start to finish, to ensure the research is useful and reflects the real experiences of people affected by bias in medical devices. Work Package 1 Mapping device use WP1a will use qualitative research methods involving observations and in-depth interviews with 30 clinicians in 5 healthcare settings to map the use of medical devices throughout pregnancy and the immediate neonatal period. WP1b will conduct a survey utilizing the Oxford-based UK Midwifery Study System (UKMidSS) to gather data on device utilization. Work Package 2 Gathering women s perspectives WP2 will use in-depth interviews with a purposively sampled cohort of 30 women, ensuring diversity in ethnicity and socio-economic status. Interviews will explore experiences with medical devices during pregnancy and the neonatal period. Work Package 3 Identifying biases WP3 involves a rapid review of literature to identify biases in the performance, availability, or usage of devices identified in WP1 and WP2 to create a prioritized list of devices guided by the PPI and Scientific Advisory Board, which will be discussed with our expert panel. Work Package 4 Research and Policy Recommendations WP4 will focus on formulating policy and research recommendations to address bias in the medical devices employed during pregnancy and the neonatal period. An expert panel—including an extended PPI group-will guide this process. Anticipated Impact and Dissemination The findings from this research will have significant impacts in ensuring that medical devices are not a barrier to equitable care. We will present findings to governmental bodies, host stakeholder roundtables, publish in peer-reviewed journals, and collaborate with national and international organizations to raise awareness while engaging communities through third sector networks.